New Delhi: Drug firm Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Perampanel tablets in various strengths.
The medication is indicated for treating partial-onset seizures with or without secondarily generalised seizures in epilepsy patients aged four years and older, and as adjunctive therapy for primary generalised tonic-clonic seizures in patients aged 12 years and older, the company said in a regulatory filing on Saturday.
The approved drug is bioequivalent and therapeutically equivalent to Catalyst Pharmaceuticals, Inc's reference listed drug Fycompa Tablets, it added.
The product will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary of the company, and is scheduled to launch in Q3 FY27.
According to IQVIA MAT data, the approved product has an estimated market size of USD 67 million for the 12 months ending August 2026.
Aurobindo Pharma now has 599 ANDA approvals from the US Food & Drug Administration (USFDA), including 574 final and 25 tentative approvals.
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